Small cell lung cancer
Conditions
Interventions
experimental group 1:20 mg/m2, 4 weeks/cycle, administered on day 1 of each cycle
experimental group 2:15 mg/m2, 3 weeks/cycle, administered on day 1 of each cycle
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with small cell lung cancer confirmed by histology; 2. Subjects with relapse or progression of small cell lung cancer after first-line platinum containing chemotherapy or radiochemotherapy; 3. Patients with ECoG score of 0-2; 4. Patients with measurable lesions according to register v1.1; 5. Patients with expected survival >= 12 weeks; 6. Patients with sufficient organ function; 7. Patients who voluntarily sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects undergoing radical surgery for small cell lung cancer; 2. Patients who had received any anti-tumor treatment 4 weeks before the first administration; 3. Patients with untreated or symptomatic central nervous system metastasis; 4. Uncontrolled pericardial effusion, pleural effusion or ascites; 5. Patients with serious systemic disease history; 6. Patients with history of autoimmune diseases; 7. The cumulative dose of adriamycin exceeds 360 mg / m2 in those patients who have previously received Adriamycin or other anthracycline treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DoR);Disease Control Rate (DCR);Progression Free Survival (PFS);Overall Survival (OS);Adverse events;Serious adverse events; | — |
Countries
China
Contacts
Public ContactKun Lou
CSPC Zhongqi Pharmaceutical Technology Co., Ltd.
Outcome results
None listed